Surgical instruments used in medical and dental practice are often stored in sealed envelopes or other containers. Other fields where sterilized instruments and equipment are desired include research laboratories, crime laboratories, and in the practice of veterinary medicine. Envelopes or other containers storing contaminated instruments undergo a sterilization process and are capable of withstanding extreme heat and have gas permeability to allow for the sterilization of the instruments. Instruments undergoing this extreme heat (autoclaving) and/or chemical treatment (chemiclaving) may be used on different patients without risk of contaminating a new patient with diseases from a previous patient who had the same instruments used on him or herself because the instruments are sterilized after exposure to this extreme heat and/or chemicals.
Commonly, in current practice, one or more unsterilized instruments are placed into a single compartment in an autoclaving receptacle. When this compartment is opened, the practitioner uses the needed sterilized instruments, and any instruments not used immediately become unsterilized, and not fit for use because they have been exposed to the unsterile environment. The unused instruments, if they are to be used on future patients, need to be resterilized in order to be fit for use. However, practitioners run the risk of using unsterilized instruments on a patient even when the instruments are located in a receptacle that has markings (such as activated autoclave tape) that indicate that the container is sterile because current methods of marking sterilized packages do not necessarily indicate that the objects within the receptacle are sterilized, only that the sterilization indicator underwent sterilization.
Indicating inks, such as chemically reactive inks or heat reactive inks are available that change color on exposure to sterilizing chemicals, or upon exposure to heat such as those disclosed in U.S. Pat. No. 4,601,588 to Takahara et al. However, the mere use of sterilization indicator devices does not verify that the instruments inside of the sterilization receptacle were there during sterilization and subjected to the sterilization process. This can occur for several reasons, one of which is that as most containers let users seal or lock the container at any time, even after sterilization has taken place, as shown by the sterilization locking device in U.S. Patent Appl. Pub. No. 20110250104 by Martel et al., where a sterilization lock can be closed after sterilization has taken place. In another type of sterilization system, as disclosed in U.S. Pat. No. 7,870,959 to Kuo et al., sterilization inks are directly printed on a sterilization envelope. While the heat changed ink indicates that the envelope has undergone sterilization, instruments can be inserted into the envelope after the envelope has undergone sterilization. This is how one can abuse and defraud currently available sterilization systems. In cases of pouches and envelopes, an empty and unsealed pouch can be placed in an autoclave until its indicator changes color, then the pouch or envelope is removed from the autoclave, filled with unsterilized instruments and sealed. Unsterilized instruments can be placed into a sterilized pouch and sealed after the envelope, but not instruments, has undergone sterilization. This color change indicator device would lead others to believe that the items in the pouch are sterilized, when in fact, they are not.
In cases of containers that use sterilization locks with heat sensitive ink printed directly on the lock, the user can place only the lock in the autoclave to have the color change, and then apply these locks to any unsterilized container to have the container and contents within the container appear sterilized. In this circumstance, unsterilized instruments are in a locked container that appears to have been sterilized, even though it is only the sterilization lock that has been sterilized. An unscrupulous user can sterilize hundreds of sterilization indicator devices and lock containers with these devices, without actually sterilizing any instruments, thus deceiving others that the contents are sterile.
Along with the above-mentioned deficiency, another deficiency of single compartment sterilization envelopes is that once the sterilization process has been completed, keeping sterilized instruments organized is difficult. The practitioner or user will have tens, if not hundreds of individual envelopes, each having a single, or a few small instruments. Envelopes may easily be lost or misplaced because of the vast number of envelopes needed in medical, dental, or laboratory procedures. Another disadvantage is that health monitoring agencies such as OSHA, dental boards, and medical boards require that each envelope show the date of sterilization. For practitioners and labs who do many procedures a day, it is cumbersome to date, sort, label, and place sterilization indicators on each envelopes, and should they choose to place multiple instruments in a single pouch to save time and cost, it would lead to the problem of exposing all instruments within pouch to an unsterile environment upon opening the pouch even when only one single instrument from that pouch is needed. The rest of the instruments within the opened pouch, if not used immediately, cannot be used on a different patient until resterilized.
Thus there is a need for sterilization containers modified for better organizing of medical instruments as well and tamper resistant devices to prevent unsterilized medical instruments from appearing sterilized.